Objectives: To assess the effect of Effect of fasting versus bedtime levothyroxin on primary hypothyroidism.
Design: A randomized clinical trial.
Setting and conduct: All eligible patients with acute or chronic brucellosis who will refer to Shahid Beheshti Hospital during the study period will be enrolled in to the trial.
Inclusion criteria: (a) patients with primary hypothyroiditis; (b) age of 18 years or older.
Exclusion criteria: (a) history of cardiovascular disease; (b) being pregnant or plan to pregnant; (c) history of malabsorption or gastritis; (d) using drug reducing levothyroxine absorption such as aluminum or sucralfate.
Intervention: Oral levothyroxine 1.6 mcgr per kg before sleep for 8 weeks.
Control: Oral levothyroxine 1.6 mcgr per kg half an hour before breakfast for 8 weeks.
Primary outcome: (a) response to treatment based on serum T4 level 8 months after treatment; (b) response to treatment based on serum TSH level 8 months after treatment.
Secondary outcome: Probable systematic adverse effects such as nausea and vomiting through history taking 8 months after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201406299014N38
Registration date:2014-07-04, 1393/04/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-07-04, 1393/04/13
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2015-08-22, 1394/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of fasting versus bedtime levothyroxin on primary hypothyroidism: A randomized clinical trial
Public title
Effect of fasting versus bedtime levothyroxin on primary hypothyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) patients with primary hypothyroiditis; (b) age of 18 years or older.
Exclusion criteria: (a) history of cardiovascular disease; (b) being pregnant or plan to pregnant; (c) history of malabsorption or gastritis; (d) using drug reducing levothyroxine absorption such as aluminum or sucralfate.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Using block randomization with group of four so that every four patents will be randomly assigned to either intervention or control groups. This process will be continued until to reach the sample size.
Blinding: The type drug in intervention and control groups is the same but the time of using drug is different. Since, blinding the time of drug usage is impossible. Therefore, the trial will be run as open label.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2014-06-25, 1393/04/04
Ethics committee reference number
D/P/16/35/9/1545
Health conditions studied
1
Description of health condition studied
primary hypothyroidism
ICD-10 code
E03.9
ICD-10 code description
Hypothyroidism, unspecified
Primary outcomes
1
Description
response to treatment
Timepoint
8 months after treatment
Method of measurement
based on serum T4 level
2
Description
response to treatment
Timepoint
8 months after treatment
Method of measurement
based on serum TSH level
Secondary outcomes
1
Description
Probable systematic adverse effects such as nausea and vomiting
Timepoint
8 months after treatment.
Method of measurement
through history taking
Intervention groups
1
Description
Oral levothyroxine 1.6 mcgr per kg before sleep for 8 weeks
Category
Treatment - Drugs
2
Description
Oral levothyroxine 1.6 mcgr per kg half an hour before breakfast for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Dr Bahareh Babeway
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Farshchian Hospital
Full name of responsible person
Dr Bahareh Babeway
Position
Resident of Internal Medicince
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Postal code
Phone
+98 81 3264 0021
Fax
Email
bahareh.babeway@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Farshchian Hospital
Full name of responsible person
Dr Mayam Vasheghani
Position
Internist
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Postal code
Phone
+98 81 3264 0021
Fax
Email
m.vasheghani@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)